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Multi-Lingual Operations / Project Manager

Work Experience

WORK EXPERIENCE:

Pfizer, Zaventem:
- Manager European Pharmacovigilance Team, Apr. 2001–Dec. 2003
- Manager Operations, European Drug Safety, Jul.1999-Mar. 2001
- Regulatory Safety Associate, European Drug Safety, Feb. 1998–Jun. 1999
- Assistant, European Drug Safety, Feb.1997–Jan.1998
- Business Assistant, Financial Services Europe, Nov.1994–Jan. 1997

PROVEN ABILITIES
*** Managing and Directing***:

• Supervised and managed daily operations of European Drug Safety team. The team was responsible for submitting serious adverse event reports to the European Regulatory Authorities. Statistics showed 100 % corporate compliance.
• Following acquisition of Warner Lambert and Pharmacia, managed and supported the European affiliates with integration of drug safety activities.
• Optimized business procedures and the information systems supporting the business procedures.
• Led five multi-national virtual teams which were responsible for enhancing the business processes supporting Drug Safety in Europe and Canada.
• Provided support to country organisations for internal and external audits/inspections and adverse event reporting process related matters.
• Led the transition activities for department following announcement of move to US. Accomplished smooth transition before deadline and closed the operations.

*** Managing data ***:

• Established and controlled the department’s budget. Every year met estimated budget figures.
• Led the communication in Europe and represented the European needs on cross-functional and global projects such as:
o the electronic reporting of adverse events,
o development of an integrated validated computer system to support the business processes of Country and Regional medical functions
o A global system to hand in adverse event reports to headquarters via a secured manner.
• Participated in the workgroup studying the new legislation for pharmacovigilance and its impact on the company’s safety processes. Informed management of possible implications.

*** Coordinating and planning ***

• Planned and coordinated the organization of European communication and training forums with attendance from colleagues from US and European cross-functional departments.
• Planned and coordinated activities for inspection preparedness within European Drug Safety. EDS was the first department in company history to pass an internal inspection without any observations at all.
• Led the activities in setting up office procedures, department’s library with applicable guidelines and directives, wrote department’s standard operating procedures and working practices
• Co-ordinated logistics and operational activities such as development & optimisation of Lotus Notes tracking database, statistics and summary reports.

*** Communication ***

• Studied, developed and maintained communication platform for Europe (eRoom technology) which was used by 46 countries to share best practices, issues, solutions and other information.
• Facilitated virtual team meetings of 5 multi-national taskforces
• Experienced in maintaining good communication with internal and external customers
• Gave presentations at company workshops and training programmes

Education

EDUCATION
Bachelor degree, Business Management - Languages, HIK, Geel, June 1994
Graduate School: Business Management-Dispatch, HIK, Geel, 1991
High School: diploma Modern Languages, Amandina College,Herk-de-Stad, 1990

Skills

TECHNICAL SKILLS
Microsoft Package Word, Excel, PowerPoint, Outlook, Lotus Notes Database, Global Pharmacovigilance Database, eRoom technology, Netmeeting and Webex, Microsoft project.

OTHER
Good knowledge of pharmacovigilance and Clincial trial regulations and guidelines

Languages

LANGUAGES
Flemish (Mother tongue)
English (Excellent)
French (Fluent)
German (Fluent)

Other

TRAINING AND DEVELOPMENT
* Professional Project Management: tools, techniques and people skills, MCE, November 2003
* Art of facilitation, Management Centre Europe (MCE), 18 – 20 February 2002
* Leading Edge, Pfizer internal course for managers, Arrowwood USA, 9-12 July 2001
* Effective Communication Skills, Rostrum, 3-4 April 2000
* Managing People, Management Centre Europe, Nov. 29 – Dec 3, 1999
* Managing across Borders, July 7 1999
* Several courses in pharmacovigilance and regulatory affairs

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